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The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.

The IPL Hair Removal Device is a hand-held device that utilizes Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device includes three models with the only difference in enclosure color. It is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission a skin sensor to detect appropriate skin contact, if the flash window is not in full contact with the skin, the device cannot emit the treatment light pulses. The device has a cooling function for a better hair remove experience.

This document is a 510(k) summary for an IPL Hair Removal Device (BE932C, BE932D, BE932E). It's a submission to the FDA seeking to demonstrate substantial equivalence to legally marketed predicate devices.

The document states that clinical testing was NOT applicable, and there is NO clinical data. This means there is no study described that proves the device meets specific acceptance criteria based on human performance or improvement. Instead, the focus is on demonstrating substantial equivalence through technological comparison and non-clinical testing.

Therefore, many of the requested details about acceptance criteria and study proving device performance are not present in this document, as they relate to clinical studies that were not performed.

However, I can extract information related to the non-clinical testing performed to demonstrate substantial equivalence.

Here's a breakdown of what is available and what is not:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria (Implicit from non-clinical testing standards): The device is required to meet various international and FDA-recognized standards for safety, electrical compatibility, and biocompatibility.
  • IEC 60601-1: 2020 (Medical electrical equipment - General requirements for basic safety and essential performance)
  • IEC 60601-1-2: 2020 (Electromagnetic disturbances)
  • IEC 60601-1-11: 2020 (Home healthcare environment)
  • IEC 60601-2-83: 2022 (Home light therapy equipment)
  • IEC 62471: 2006 (Photobiological safety)
  • ISO 10993-5: 2009 (Biocompatibility - In Vitro Cytotoxicity)
  • ISO 10993-10: 2021 (Biocompatibility - Skin Sensitization)
  • ISO 10993-23: 2021 (Biocompatibility - Irritation)
  • FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices" (Software verification and validation)
  • "Applying Human Factors and Usability Engineering to Medical Devices" (Product usability)
• Reported Device Performance: The document states that "The testing results demonstrate that the subject device complies with the following standards" and lists the standards above.
  • Technological similarities to predicates are also presented as a form of performance equivalence (e.g., wavelength, output energy, pulse duration within range of predicates).

2. Sample size used for the test set and the data provenance

• This document is for a non-clinical submission. There is no "test set" in the sense of a clinical trial. The testing refers to engineering tests performed on the device itself.
• Data provenance: Not specified, but generally, these tests are conducted by the manufacturer or accredited testing labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable as there is no clinical test set or human "ground truth" establishment in this filing. The "ground truth" for non-clinical testing is adherence to the specified engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There's no human reader component that would require an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "The clinical test is not applicable, there is no clinical data."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable in the context of an AI algorithm as this is an IPL device, not an AI diagnostic tool. Software verification and validation were performed for the device's inherent software.

7. The type of ground truth used

• For the non-clinical tests, the "ground truth" is compliance with established international and FDA-recognized engineering, electrical, photobiological safety, and biocompatibility standards. The device is being compared to its predicate devices for technological equivalence rather than against a clinical ground truth like pathology or patient outcomes.

8. The sample size for the training set

• Not applicable. There is no AI model or training set described.

9. How the ground truth for the training set was established

• Not applicable.

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